Shots:

• The NMPA has granted CTA approval to AffaMed to conduct a clinical study evaluating AMT901/ SB3- a biosimilar referencing Roche’s Herceptin. The company is preparing for clinical study with its anticipated first patients visit in Q1’20
• The CTA approval is based on the results of the study demonstrating bio-similarity of AMT901 to Herceptin with no clinical differences in efficacy & safety in patients with HER2 + BC
• AMT901/SB3 is an IV trastuzumab being developed in collaboration with Samsung Bioepis for the treatment of HER2+ BC and is an approved therapy in the US and EU. In Feb’2019- AffaMed and Samsung Bioepis collaborated to develop & commercialize multiple biosimilars in China

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: GlobeNewswire